Conducting Clinical Trials to the Highest Standards

Clinical trials are at the heart of biomedical progress, and we recognize that volunteers are unsung medical heroes of our day. We are working to enhance our clinical trial infrastructure to ensure that all of our trials are done to the highest standards and protect the rights and welfare of the trial participants who make our progress possible.

Wherever we conduct clinical trials, we do so in accord with the highest ethical, safety and scientific standards. Across a wide range of research units, therapeutic areas and diseases, approximately 2,000 Pfizer clinical and medical colleagues share responsibility for conducting hundreds of clinical trials involving thousands of investigators, research coordinators and study site personnel. Over 150,000 patients are involved in these trials.

Last year, we launched the Clinical Trial Excellence Initiative, a reengineering and quality improvement initiative to optimize the management of our trials to ensure quality and compliance across all of our clinical trials. This initiative, under the direction of a Pfizer senior vice president reporting to the company's Chief Medical Officer, should be completed late in 2011. When it is, Pfizer will have additional state-of-the-art capabilities for clinical trial design, development and execution.

We have sponsored a number of initiatives with stakeholders and partners to help advance research integrity and ethics. For example, we convened a 50-organization summit on Global Clinical Trials that resulted in a white paper on opportunities for improving multiregional clinical trials, posted on Pfizer.com/development. We have been working with Harvard to establish a center on multiregional trials to implement some of these ideas and find others. We commissioned a clinical trial manual, "Reviewing Clinical Trials: A Guide for the Ethics Committee," that was proposed and sponsored by Pfizer and authored by experts from the University of Hong Kong, the Association for Accreditation of Human Research Protection Programs (AAHRPP) and leading bioethicists from around the world. Finally, we were the first and only pharmaceutical company to pursue and obtain full AAHRPP accreditation of our Phase I clinical research units.

Global Standards

We have run trials in over 60 countries, and increasingly in the developing world, which has unique challenges. To ensure patient safety and ethical conduct throughout the study, we follow global policies and standard operating procedures for our clinical trials wherever they are run. Our policies and processes require that informed consent, independent ethics review, post-study care and the use of placebos conform to established international ethical standards. To ensure informed consent, we have invested in programs such as "talking books" that illustrate the advantages and disadvantages of clinical trial enrollment in simple-to-understand words and illustrations.

We also engage in local capacity building. Capabilities of local investigators and research sites are carefully reviewed by a study team and can be included in the trial only if the investigators have sufficient knowledge, expertise and infrastructure to conduct a clinical trial in accordance with Good Clinical Practice. We provide training in Good Clinical Practice to all investigators and all sites. We have developed a certification program for our clinical research staff and contractors, with over 1,000 colleagues and contractors now having successfully completed this certification program.

To ensure ethical conduct, we have detailed monitoring plans for each trial, and review the data and human subject protection procedures at each site over the course of the trial. In 2010 Pfizer conducted over 50,000 monitoring visits at 13,000 sites around the world, as well as several hundred internal audits of these sites to assess adherence to good clinical practice and pharmacovigilance requirements. Regulators from the U.S., Europe, Japan and elsewhere also regularly audit our trials and the local trial sites in the U.S. and abroad, to ensure that the data is trustworthy. When we conduct trials that are blinded (that is, neither we nor the investigators know which patient is getting the study drug or a different drug), we utilize independent data monitoring committees (DMCs) if mortality or major morbidity is an endpoint or if there are other known safety concerns. The DMC provides an external assessment of interim data and advises us whether a trial may need to be suspended or terminated to protect patient safety. Last year, we had over 80 different data monitoring committees overseeing Pfizer trials around the world.

Improving the Odds to Deliver New Treatments, Cures and Vaccines

The overwhelming majority of compounds tested in the laboratory fail to move beyond the testing stage and only a relative handful move on to more advanced tests for efficacy and safety. Among those that do advance, many fail at the clinical trial stage. We are among the leaders in exploring and, where appropriate, using quantitative approaches to improve R&D productivity by picking likely "winners" earlier in the development process. In concert with regulators in the U.S. and elsewhere, Pfizer is advancing adaptive clinical trial approaches that may, over time, change the ways clinical trials are executed, and gain more information from the use of fewer human volunteers. We are even exploring programs that may harness massive computing power to create "virtual" clinical trials, giving indications early on how best to move ahead using human volunteers.

We are also working on innovative ways of conducting clinical trials with broadly distributed patient populations using remote monitoring and self-reporting. Initial efforts to test the concept focus on post-marketing (or Phase IV) clinical trials.